HOUSTON, Texas — (August 26, 2025) — GreenJay Therapeutics, Inc. (“GreenJay” or the “Company”), a late-stage pharmaceutical company focused on developing life-changing therapies for patients requiring stem cell/bone marrow transplants, announced today that the Company has manufactured its registration batches necessary for regulatory approval. Previously, GreenJay completed its preclinical toxicology studies. GreenJay has developed an improved formulation of IV busulfan (BULANTA TM ).
“Our improved formulation does not contain dimethyl acetamide (DMA), which is currently used in IV busulfan formulations at a dose 1000 times the Daily Permitted Exposure,” said Borje S. Andersson, MD, PhD, Scientific Founder of GreenJay and inventor of BULANTA.” Currently, all IV busulfan products on the market contain this toxic solvent. Stem cell transplant conditioning is a treatment given to patients prior to stem cell transplantation in order to destroy abnormal blood or cancer cells.
“The successful completion of this final step in our scaled-up clinical grade manufacturing of BULANTA TM marks a key manufacturing milestone for GreenJay, and is credited to the hard work and commitment of both our internal personnel and our manufacturing partners,” said Michael T. Redman, President and Chief Executive Officer of GreenJay. “This significant milestone paves the way to complete the Chemistry, Manufacturing and Controls (CMC) modules necessary for FDA approval through the 505(b)(2) pathway.”
IV busulfan is currently approved by the FDA to treat Chronic Myeloid Leukemia, but is widely used to treat several leukemias, lymphomas and genetic diseases such as sickle cell disease and thalassemia. In particular, IV busulfan is used to treat more than 80% of patients with Acute Myeloid Leukemia who receive myeloablative conditioning, according to the Center for International Blood and Marrow Transplant Research (CIBMTR, 2024).
About GreenJay
GreenJay Therapeutics, Inc. is a drug formulation company focused on developing drug products with greater drug solubility, improved safety profiles and greater efficacy. The Company’s lead product candidate, BULANTA (IV busulfan), is being developed as an alternative to other IV formulations of busulfan that contain the toxic DMA solvent. BULANTA is in late-stage development as a conditioning agent for stem cell transplantation. For more information, please visit the Company’s web site at www.greenjaytherapeutics.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effect of GreenJay Therapeutics’ product candidates, alone and in combination with other therapies, regarding the Company’s future growth and financial status and regarding our commercial partnerships. Risks that contribute to the uncertain nature of the forward-looking statements include the presence and level of the effect of our product candidates, alone and in combination with other therapies; the success of our strategic partnerships, including those relating to manufacturing of our product candidates; the timing and success of obtaining FDA approval of our product candidates, including whether we receive fast track or similar regulatory designations; and costs associated with developing our product candidates.
All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
GreenJay Therapeutics, Inc.
mredman@greenjaytherapeutics.com